Status:
COMPLETED
Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Cholecystitis, Acute
Eligibility:
All Genders
18+ years
Brief Summary
This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients...
Detailed Description
Acute cholecystitis is a common surgical condition. However, in elderly patients or patients with significant comorbidity, emergency laparoscopic cholecystectomy can be associated with significant ris...
Eligibility Criteria
Inclusion
- Consecutive patients with acute cholechystitis unsuitable for surgery
- age ≥ 18 years old
- Written informed consent from patient or guardian who is able to understand the nature and possible consequences of the study
Exclusion
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients with suspected gangrene or perforation of the gallbladder
- Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal)
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
- Patients with liver cirrhosis, portal hypertension and/or gastric varices
- Abnormal coagulation (INR \> 1.5 and/or platelets \< 50.000/mm3)
- Contraindication to perform endoscopy
Key Trial Info
Start Date :
May 6 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 15 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04874103
Start Date
May 6 2020
End Date
September 15 2023
Last Update
February 14 2024
Active Locations (1)
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1
Universita' Cattolica del Sacro Cuore
Rome, Italy, 00136